Actively Recruiting
Clinical Study of Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History Caused by Abnormal Uterine Natural Killer Cells
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2025-11-17
14
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor
T
The University of Science and Technology of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to explore the effectiveness and duration of autologous decidual-like natural killer (NK) cells therapy in improving uterine NK cell dysfunction in women with infertility or a history of adverse pregnancy outcomes. It focuses on patients with abnormal uterine NK cell function and fertility needs, seeking to understand how this therapy might help with such reproductive challenges. The treatment involves collecting peripheral blood from each patient to isolate and culture autologous decidual-like NK cells in the laboratory. These cells are then infused into the patient's uterus through intrauterine perfusion. If the uterine NK cell function improves within six months after the first treatment, the patient can attempt pregnancy, with follow-up of pregnancy outcomes. If there is no improvement, a second infusion of the same therapy may be given, with up to two treatments total. Participants will undergo continuous menstrual blood analysis for six months to monitor uterine NK cell function after treatment. Researchers will also track pregnancy outcomes, including clinical pregnancy, ongoing pregnancy, live birth, preeclampsia, and fetal growth restriction for up to one year after therapy completion. The study includes safety and effectiveness assessments during this follow-up period, with a total participation duration extending to about one year after treatment.
CONDITIONS
Brief Title
Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Abnormal uterine NK cell function
- History of at least one of the following: unexplained recurrent spontaneous abortions (2 or more), repeated implantation failure (at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension, or early-onset fetal growth restriction
- Clear fertility desire
- Normal ovarian function or presence of frozen embryos
- Endometrium thickness of 7 mm or more measured by vaginal ultrasound before ovulation or at mid-luteal phase
- Body mass index between 18 and 30 kg/m²
You will not qualify if you...
- Use of progesterone receptor modulators
- Chromosomal karyotype abnormalities in either spouse
- Severe endometriosis, uterine fibroids affecting uterine shape or size larger than 2.5 months of pregnancy, uterine malformation, uterine adhesion, or thin endometrium
- Uncontrolled autoimmune diseases
- Abnormal blood coagulation, liver or kidney function, or other uncontrolled diseases such as hypertension, diabetes, or thyroid disease that may affect the study
- History of pelvic malignant tumors
- Current participation in other clinical studies
- Allergy to blood products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive up to 2 intrauterine infusions of autologous decidual-like natural killer cells isolated and cultured from their peripheral blood.
Initial treatment visit and up to 1 repeat infusion visit
Duration - Up to 1 year after completion of therapy
Participants undergo continuous menstrual blood analysis to assess uterine NK cell function improvement and attempt pregnancy with follow-up on pregnancy outcomes.
Regular follow-up visits during 6 months post-treatment and pregnancy outcome visits up to 1 year
Trial Site Locations
Total: 1 location
1
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
Y
Yali Hu
H
Hui Zhu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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